Senior Supplier Quality / Quality Systems Engineer

Finish Line Staffing Services is seeking an experienced Senior Supplier Quality / Quality Systems Engineer to support supplier quality oversight and Quality Management System (QMS) improvements within a medical device environment. This role will focus on managing supplier audits, ensuring regulatory compliance, and reviewing and enhancing quality procedures.

The ideal candidate is a detail-oriented professional with strong supplier quality and quality systems experience who can work independently and drive continuous improvement.

Key Responsibilities

• Plan, conduct, document, and follow up on supplier audits.
• Manage supplier qualification, performance monitoring, and periodic re-evaluations.
• Identify supplier compliance gaps and drive corrective actions through resolution.
• Review, revise, and improve Quality SOPs and related documentation.
• Ensure procedures align with ISO 13485, FDA requirements, and internal quality standards.
• Support CAPA, change control, document control, and audit activities.
• Evaluate existing quality processes and recommend improvements to compliance and effectiveness.
• Maintain accurate audit reports, quality records, and supporting documentation.

Qualifications

• Extensive experience in Supplier Quality and Quality Systems within the medical device industry.
• Strong knowledge of ISO 13485 and FDA Quality System requirements.
• Proven experience managing supplier audits and corrective actions.
• Hands-on experience developing and updating Quality SOPs.
• Working knowledge of CAPA, change control, document control, and QMS processes.
• Excellent technical writing, analytical, and problem-solving skills.
• Ability to work independently, manage priorities, and deliver results with minimal supervision.